1.0 PROCEDURE Dextrose Injection IP (25% w/v)
1.1 Sampling and Handling
1.1.1 Quantity of Composite Sample for Analysis
100 ml in well closed container.
1.1.2 Quantity of Reserve Sample
100 ml in well closed container.
1.1.3 Label Claim of Dextrose Injection IP (25% w/v)
Each 100ml Contains:
Dextrose Anhydrous IP……25.0% w/v
Water for Injections IP……..q.s.
1.2 Test and Method
1.2.1 Description: A clear colorless to faintly straw yellow color solution.
1.2.2 pH
Dilute 20 of sample to 100 ml with distilled water and measure the pH value of resulting solution at 25°C on suitable calibrated pH meter.
Limit: 3.5 to 6.5
1.2.3 Assay:
Dextrose Anhydrous: (By Polarimeter)
Procedure:
Transfer 20.0 millilitre of sample in 100.0 ml volumetric flask, add 0.02 ml of 5 M Ammonia and sufficient distilled water to produce 100.0 ml. Mix well and allow to stand for 30 minutes and determine the optical rotation in 2-dm tube on suitable calibrated Polarimeter at 25ºC using distilled water as blank.
(Limit: 24.50% w/v to 25.50% w/v)
Calculation:
Calculated the content of Dextrose in % wt./vol by following expression:
Observed Angle of rotation X 0.9477 X 5.0 ……………………..=% wt./vol.